Monday, March 9, 2015

In framing Bruce E. Ivins, the government germ-warfare scientist, for responsibility for the 2001 anthrax "mailings," which reputedly claimed five lives, and undisputedly terrorized the civilian nation, intelligence-agency narrators rely on two main aspects, as evidenced in David Willman's Los Angeles Times article, Suspect stood to gain from anthrax panic, published three days after Ivins' demise, when the coast was clear.
One motive attributed to Ivins was first proffered by Nicholas Kristof in January 2002 when the agenda was pinning the atrocity on Ivins' former colleague Steven Hatfill. Let's call this defense the "innocent attention whore clamoring for a larger slice of the pie" justification. As Willman put it of Ivins in 2008:

One former senior official with Ivins' employer, the U.S. Army Medical Research Institute of Infectious Diseases, whom the FBI questioned at length about Ivins, said he believed his former colleague wanted more attention -- and resources -- shifted to biological defense.

"It had to have been a motive," said the former official, who suspects that Ivins was the culprit. "I don't think he ever intended to kill anybody. He just wanted to prove 'Look, this is possible.' He probably had no clue that it would aerosolize through those envelopes and kill those postal workers."

There are two major things wrong with this point of view. First---in the years leading up to September 11th, and the October Anthrax Fest that followed, the media record is filled with an escalating drumbeat of manufactured bioterror threats. Apparently, the specialized horror budgets were spiking too--albeit, not in the insane "move the decimal point over till I say when" way which marked the later Bush presidency, but certainly flush enough so that Ivins wouldn't have to take the 1972 Biological Weapons Convention to heart. Secondly, Ivins was an over-twenty-year man in 2001. Various reports have him with 28 to 36 years in service when he "retired" in 2008. (Ivins' Wikipedia entry quotes this Los Angeles Times article, which wrongly says Ivins had been working at Fort Detrick for 18 years. Ivins obituary in the Frederick News-Post reports on his career, only that "Dr. Ivins was a scientist for 36 years, at USAMRIID at Fort Detrick.")

Could researching deadly germs really be so engrossing that he could overlook decades of government bureaucracy and petty office politics and not dream of that villa in Fort Meyers?

The second motive was financial---Ivins "stood to gain financially from massive federal spending in the fear-filled aftermath of those killings," because he held in partnership two patents on anthrax vaccine components. The narrative has to tread carefully here, because Ivins never did benefit from the new "massive federal spending." Apparently, Ivins had a hand-shake agreement with one of two biotechnology companies, VaxGen, which had "won a federal contract worth $877.5 million." But here the narrative goes completely screwy:

One executive who was familiar with the matter said that, as a condition of its purchasing the vaccine from the Army, VaxGen had agreed to share sales-related proceeds with the inventors.

But wasn't VaxGen supposed to sell vaccine to the Army? And if VaxGen was simply acting as a fabricator of an Army invention which was to be sold back to the Army as consumer then doesn't much of the onus of its failure to "deliver its batches on schedule" fall on Dr. Ivins' shoulders?

Likewise, Ivins' second patent---actually a "patent pending," required that "the Pentagon's Defense Advanced Research Projects Agency commit[..] $12 million for additional testing of the experimental additive," which doesn't speak of much presumptive inventorship.

But Ivins was always helpful:

He also played a lead role in helping a private company, BioPort, win regulatory approval to continue making the vaccine required for U.S. service personnel deployed to Iraq, Afghanistan and other regions.

However, it took five or six years after BioPort had privatized the state-owned manufacturer before they could turn out their first acceptable dose of vaccine. As the New York Times wrote at the time of the sale in 1998

The rickety plant, which has been run by the Michigan Department of Community Health, has lost millions of dollars annually for years. So in 1996 Michigan decided to sell it to the highest bidder. No one was seriously interested, even after the Pentagon announced it would pay for a $1.8 million renovation.

Then in 2001, with the vaccine still not forthcoming, the Times fumed that the Defense Department had "invested $126 million in the Lansing plant over the last decade."

"We are jumping from vaccinating 150,000 in the Gulf War to 2.4 million on shaky ground,'' said Col. Redmond Handy, a reserve officer.

Before we get into the topic of who really "stood to gain from anthrax panic," I think it imperative we understand our jumping off point, which helps explain why the totally inexperienced, and totally entitled men behind the BioPort incorporation had such a hard time of it.

The Food and Drug Administration yesterday altered a long-standing regulatory policy, making it possible for U.S. troops serving in the Persian Gulf to be given experimental drugs without their consent. The new "interim rule," established at the request of the Defense Department, is intended to provide flexibility in countering the effects of chemical and biological weapons. Published in the Federal Register yesterday, the policy went into effect immediately because of "the urgency created by current military operations in Operation Desert Shield." The policy gives the FDA authority to permit administration of "investigational drugs and biologics" without obtaining the "informed consent" of soldiers if the commissioner of food and drug deems that such consent "is not feasible" in battlefield conditions. …Archived

The State of Michigan yesterday approved the sale of the nation's only licensed manufacturer of anthrax and rabies vaccine to a company led by Adm. William J. Crowe Jr., a former Chairman of the Joint Chiefs of Staff and the United States Ambassador to Britain until last year.

The sale of the Michigan Biologic Products Institute, the last state-owned vaccine laboratory in the United States, gives Admiral Crowe's newly formed company, the BioPort Corporation, an inside track on at least $60 million in Pentagon contracts for anthrax vaccine to protect the nation's 2.4 million members of the armed forces and reservists against an anthrax attack.

The rickety plant, which has been run by the Michigan Department of Community Health, has lost millions of dollars annually for years. So in 1996 Michigan decided to sell it to the highest bidder. No one was seriously interested, even after the Pentagon announced it would pay for a $1.8 million renovation.

The situation changed in December 1997 when the Clinton Administration threatened to go to war over Baghdad's intransigence in giving free access to United Nation's inspectors. Defense Secretary William S. Cohen announced that all American troops and reservists would get anthrax shots -- a first for the military.

WASHINGTON (CNN) --A shipment of 200,000 doses of anthrax vaccine destined for U.S. troops in the Persian Gulf was stopped because it apparently had frozen during shipment, destroying its effectiveness, CNN has learned.

At $3.50 per dose, the shipment is valued at some $700,000, defense officials said. It is not clear when the temperature change took place.

The problem was discovered about two weeks ago. Another shipment of 200,000 doses was sent shortly thereafter to replace the damaged batch, so the inoculation of troops in the Gulf could take place on schedule, to protect them against the potentially lethal germ-warfare agent.

The first in a series of shots is to be administered to troops next week.

Officials, speaking on the condition they not be named, said the vaccines were shipped from Mechanicsburg, Pennsylvania, to Germany en route to the Middle East.

In Germany, someone noticed that at least one of the 20,000 vials had suffered a radical temperature change, apparently freezing and rendering the doses useless.

Army Surgeon Lt. Gen. Ronald Blanck sent specialists to Germany to examine the shipment to see if any of it could be salvaged. The results of their examination are not yet available, the officials said.

CNN Military Affairs Producer Chris Plante contributed to this report.

LANSING, Mich. (AP) -- The sale of the nation's only licensed maker of anthrax and rabies vaccine passed its final state hurdle, with approval of a deal to sell the state-owned laboratory to a company led by a former chairman of the Joint Chiefs of Staff.

A state board voted unanimously Tuesday to allow the sale to newly formed BioPort Inc., which has bid $25 million to buy the Michigan Biologic Products Institute. Payment would be made in a combination of cash, secured notes, product donations and royalties.

Among those attending the State Administrative Board's meeting was retired Adm. William J. Crowe Jr., former chairman of the Joint Chiefs of Staff in the Reagan administration and director of Intervac L.L.C., a pharmaceutical investment firm based in Maryland.

The company almost certainly stands to benefit from President Clinton's expansion of the Pentagon's anthrax vaccination program to include all 2.4 million U.S. military personnel.

Once the sale is closed, BioPort plans to negotiate with the Pentagon to make enough vaccine for the inoculations at an estimated cost of $130 million, including funds to renovate the aging lab.

"We've got a lot of hard work ahead of us,'' said Crowe. "The heart and soul of this business is the U.S. government. That is our No. 1 priority.''

Crowe, 73, was the U.S. ambassador to Britain from 1994 to 1997 and served as chairman of the Joint Chiefs of Staff from 1985 to 1989.

The board approval was BioPort's last state hurdle. Michigan would be responsible for any contamination found during its environmental study of the 60-acre Lansing site. Once that process is finished, the sale contracts could be completed.

The lab has drawn international attention as the only source of anthrax vaccine in the nation. It opened in 1926 and is the last state-owned vaccine lab in the United States.

Gov. John Engler said he was pleased the aging lab that for years has been losing millions of dollars would go into private hands, where it is expected to prosper.

Crowe's Intervac is the major investor in BioPort, with 58 percent. Other partners are Neogen Corp., a Lansing-based food safety research and development company, with 10 percent ownership, and the lab's managers led by Director Robert Myers, who have a 32 percent stake, according to BioPort documents.

The offer includes $3.25 million in cash at closing, $12.1 million in secured notes, $4.6 million in rabies vaccine and immune globulin donations to the state and $5 million in royalties over five years.

WASHINGTON (AP) -- Pentagon officials came under sharp questioning Wednesday about plans to inoculate 2.4 million members of the armed forces against anthrax.

"Why this vaccine?'' Rep. Christopher Shays, R-Conn., asked at a hearing of the House Government Reform's subcommittee on national security.

Up to 200 service members have refused to take the vaccine. The Pentagon has said that 220,000 have been vaccinated.

"Anthrax is the primary biological warfare threat faced by U.S. forces,'' Sue Bailey, assistance defense secretary for health affairs, told the panel. She said the anthrax vaccine was tested by the Food and Drug Administration and found safe, a determination confirmed by an independent review.

"There have been no long-term side effects reported with the FDA-licensed anthrax vaccine,'' which has been in use since 1970, she said.

Shays said there was a lack of trust in the Pentagon program and he said the military's efforts to counter concerns "seem heavy-handed and one-sided, glossing over legitimate concerns about the safety and efficacy of the vaccine, minimizing adverse reaction reports, and blaming the Internet for fanning dissent.''

Also testifying were many critics of the mandatory policy adopted by the Pentagon.

"We are jumping from vaccinating 150,000 in the Gulf War to 2.4 million on shaky ground,'' said Col. Redmond Handy, a reserve officer.

"By implying we are protected from anthrax may place many soldiers in more danger,'' said Capt. Thomas Rempfer, who quit the National Guard after completing a report on the anthrax vaccine.

It was the first of several hearings the committee plans on this issue and the committee plans to call the FDA to testify next.

"We will follow it until we are sure medical force protection means assuring the long-term health of U.S. forces not just short-term mission capability,'' Shays said.

WASHINGTON (AP) --The program to vaccinate all 2.4 million military troops with the anthrax vaccine as protection against biological warfare may be delayed while the only c

BioPort Corp. of Lansing, Mich., the sole producer licensed for manufacture of the vaccine in the United States, is experiencing a cash-flow crisis, a congressional memo says.

The House Government Reform Committee's national security subcommittee has scheduled a hearing today on the Defense Department's reliance on the company.

"The Pentagon is locked in a dependent relationship with a new, unproven company,'' according to Rep. Christopher Shays, R-Conn., the panel's chairman. He said the Pentagon "may have misjudged the financial and technical capabilities of the company to perform under the contract.''

In a memo sent last Friday to members of his panel, Shays said the General Accounting Office and recent reviews by the Defense Contract Audit Agency indicate the company has "a cash flow crisis.''

Defense Secretary William Cohen last year ordered all 2.4 million active duty and reserve troops to get the anthrax vaccine as protection against biological warfare. Nearly 300,000 service members have been immunized so far, though there have been scattered cases of some troops refusing the inoculations out of safety concerns.

Last year, the Pentagon awarded BioPort a contract valued at $29 million to produce the vaccine against anthrax, which can be used as a weapon when spores are released into the air and people inhale them.

To make the vaccine, BioPort is seeking an advance payment of $10 million -- an approximately five-fold increase in the per-shot price to about $20 -- and permission to sell up to 300,000 doses each year on the open market.

In testimony prepared to be delivered before the House panel, Fuad El-Hibri, president and chief executive of BioPort, said "the prices paid by the Defense Department for (the anthrax vaccine) are significantly below'' the company's costs for producing it "and what is necessary for BioPort to operate as a viable entity.''

A spokeswoman for BioPort, Kelly Rossman-McKinney, said BioPort's move to restructure the deal was reasonable. Before the company went private last year, it was selling shots well below cost and the state of Michigan was losing about $5 million subsidizing the lab, she said.

BioPort was formerly a state-owned facility called the Michigan Biologics Products Institute. In March 1997, the Food and Drug Administration warned the facility that steps would be taken to revoke its production licenses, including for anthrax vaccine, if it did not correct quality control deficiencies and manufacturing violations.

In March 1998, the plant was closed for $1.8 million in renovations and a $15 million expansion funded by the Defense Department.

In September, BioPort purchased the facility. The new vaccine manufactured by BioPort is not expected before late 1999, congressional aides said.

Rossman-McKinney said the plant now has good quality control.

The Pentagon agreed to take on legal liability if the vaccine harms anyone under a deal Army Secretary Louis Caldera approved last fall.

The Defense Department described the arrangement as routine and a cost saver. Without government protection from lawsuits, the company would have to buy expensive outside insurance, with the cost passed on to the government as part of the contract price, said Army Col. Dick Bridges, a Pentagon spokesman.

With nearly 900,000 shots administered so far, the vaccine has produced just 79 "adverse reactions,'' the Pentagon said.

The only U.S. company that produces anthrax vaccine has run into serious financial trouble, imperiling a Pentagon program launched recently to immunize all U.S. troops against the deadly germ warfare agent.

Top officials from BioPort Corp. said yesterday that renovation delays and other transition problems after their purchase of the vaccine production facility from the state of Michigan have pushed the company close to bankruptcy. Unless the Pentagon agrees to more than triple the price it pays for the vaccine--from $3.50 to about $10 per dose--company officials suggested they have little hope of meeting the terms of a $29 million contract with the Defense Department.The fact that the contract is proving untenable only months after BioPort took over the plant last autumn drew expressions of alarm and exasperation from Rep. … >
_________________________________________________________________________________

Allegations of ethical misconduct surround the start-up company that has become a multimillion-dollar supplier of anthrax vaccine to the Pentagon.

Coming seemingly from nowhere, the Lansing, Mich.-based biotech company in its first year of existence landed a multimillion-dollar contract for perhaps the greatest weapon ever employed by the military: an anthrax vaccine. But it hasn't come easily. Rocked by allegations of ethical misconduct, financial chaos and dangerously sloppy management practices involving two former Michigan lab directors who were hired by BioPort Corp., the company now finds itself the target of a federal probe.

Republican Rep. Walter Jones Jr. of North Carolina, a member of the House Armed Services Committee, requested the Defense Department's, or DOD's, inspector general to investigate the Pentagon's financial relationship with BioPort. "I believe we have a skunk," Jones tells Insight. "I just can't find out where the odor is."

The federal probe comes on the heels of the Pentagon announcing it doubled the sole-source contract to purchase the vaccine, from $25.7 million to $49.8 million, in an effort to help stabilize the financially troubled company. Under the new contract, BioPort will provide about 2.3 million fewer doses than previously requested, for a total of about 5.3 million doses. The Pentagon says the expected deliveries still will be enough to administer the vaccine to all those who need it.

But the terms of the deal are raising questions: The Pentagon also agreed to advance BioPort $18.7 million to cover its debts. BioPort claimed unless the Pentagon paid the up-front money, military authorities would not have enough vaccine to inoculate all 2.4 million U.S. troops.

Jones calls the $18.7 million advance disturbing. "Why is the taxpayer doing it, if it is not mandated?" he asks.

In a letter Jones sent to DOD Inspector General Donald Mancuso, he says, "While I understand the need to revisit contracts between the government and its suppliers, I am increasingly concerned about the nature of the relationship between DOD and BioPort Corporation.... [D]espite serious questions regarding the overall viability of BioPort, the federal government has chosen to more than double the value of its existing contract.

"If a company is to be the sole producer of a vaccine for every member of our armed forces, it is imperative that every aspect of the relationship with that company be sound," Jones continued. "Failure to follow that principle jeopardizes the health and safety of the men and women in our military, as well as that of their families."

Jones cited recent congressional testimony from the Government Accounting Office that BioPort is having financial difficulties, along with a DOD audit that indicated "substantial doubt that BioPort will be able to continue performing its contract."

The financial mess BioPort finds itself in also has caught the eye of the state of Michigan. Officials there wonder whether BioPort can make an $8.7 million payment by Sept. 4, according to a source familiar with the deal that turned the former state-owned lab over to BioPort for a total price tag of about $24 million.

The advance funds from the Pentagon cannot be used to make the Sept. 4 payment under the terms of the contract signed with the state. BioPort says it has every intention of making its payment deadline as it has on its previous payments. The only technical violation reported against the company is that BioPort has yet to honor product commitments to the state. Part of the state deal called for BioPort to provide rabies vaccine and plasma derivatives. But because BioPort has yet to get Food and Drug Administration, or FDA, approval to run their new lab, they haven't been able to provide the rabies vaccine. Even if BioPort fails to make the Sept. 4 payment, Michigan likely would grant an extension because, as one employee says, "The state doesn't want the bricks back. … ________________________________________________________________________________

Democratic Michigan state Rep. Lling Brewer has introduced a state resolution demanding Congress initiate a criminal investigation of BioPort Corp., now the sole supplier of the anthrax vaccine for 2.4 million American troops.
Michigan once produced the anthrax vaccine but sold its facility and plant to BioPort last year for $24 million. Brewer initiated a state ethics investigation concerning the sale but that probe failed to unearth any crimes. Brewer had complained that two board members of BioPort used to work for the state of Michigan and could have had inside information about the bidding process. He told Insight in September that "the buyers became sellers and the sellers became buyers" (see "Why BioPort Got a Shot in the Arm," Sept. 20, 1999).
Brewer also objected that BioPort's chief executive officer was Faud El-Hibri, who helped facilitate the purchase of anthrax vaccine for Saudi Arabia, which had been unable to obtain it from the U.S. government. Even more surprising to Brewer was that there was no national-security review of the BioPort sale. …

LANSING, Mich., Oct. 5 — With concern growing over the possibility of biological weapons being used against Americans, anthrax vaccine should be pouring out the door of the only laboratory in the United States licensed to make it.

But although the laboratory is working frantically to meet government standards so it can begin producing the vaccine, it has failed to do so. As a result, the government program aimed at vaccinating all American soldiers against anthrax is at a standstill.

On Monday, National Guard sentries arrived to guard the plant, which is owned by BioPort Corporation, but the sole supplier of anthrax vaccine to the military has not produced a single dose since 1998, when it bought the plant from the state.

Problems have plagued BioPort from the beginning. It failed Food and Drug Administration inspections in 1999 and 2000; inspectors cited problems including poor documentation and improper procedures in the room where the vaccine was packaged. Corporate managers hope to begin producing anthrax this year, but that depends on the outcome of a third F.D.A. inspection, which has not yet been scheduled.

At a hearing of the Senate Armed Services Committee last year, Senator Tim Hutchinson, Republican of Arkansas,called BioPort's record "an unmitigated disaster." Mr. Hutchinson said its failures were "costing the American taxpayer millions and millions of dollars and jeopardizing the safety of our troops who we're not able to provide that anthrax vaccination."

Others say that problems are not all the fault of the laboratory, which started life as the Michigan Biologic Products Institute before it was bought by BioPort.

"There's a lot of criticism of BioPort," said Tara O'Toole, deputy director of the Center for Civilian Biodefense Studies at Johns Hopkins University, "but to be fair, there's also a lot of talk that the Defense Department significantly underfunded the whole effort and didn't give it the priority it deserved."

"In retrospect," Ms. O'Toole said, "the whole notion of turning this over to a new contractor instead of an established pharmaceutical company looks questionable."

Plant officials say that since the terror attacks last month on the World Trade Center and the Pentagon, their 220 employees have been working with new fervor.

"Our commitment has deepened measurably," said Kim Brennen Root, a BioPort spokeswoman. "People are getting up every morning thinking: `I know what my job is. I know what I have to do and I have a very clear purpose.' "

The only other plant that produces anthrax vaccine, Ms. Root said, is in Britain.

Many experts believe that if terrorists were to launch an attack using biological agents, anthrax would be among their most likely choices. Although anthrax is said to be difficult to produce and spread in large doses, an enemy that managed to do so could inflict considerable damage. A 1993 government study found that spraying just 220 pounds of aerosol anthrax over Washington could kill up to three million people.

The Soviet Union was known to have experimented with military uses of anthrax, as have about 10 other countries, including North Korea and Iraq. Some reports say that Osama bin Laden, whom Bush administration officials describe as head of the world's principal terror network, has also taken an interest in chemical and biological warfare.

"It's a good bio-terror weapon and even better for biological warfare, and it's lying on the ground in places like Afghanistan" said William Dietrich, an assistant professor at Harvard Medical School who is researching the anthrax bacterium. "If you have a collection of soldiers you want to kill without infecting your own population or soldiers," Professor Dietrich said, "anthrax has good properties with regard to that. If you can produce it and disperse it on a battlefield, you can kill a lot of people very quickly. It's a very terrible, high-fatality kind of illness that we don't have enough tools in our arsenal to stop."

In the Persian Gulf war, when what is now the BioPort plant was still run by the State of Michigan, thousands of American soldiers were given an anthrax vaccine made here. Some later charged that it contributed to the mysterious illnesses, sometimes referred to as gulf war syndrome, that afflicted some veterans of the conflict. In recent years, more than 400 soldiers have been disciplined for refusing to take the anthrax vaccine, and others have complained of adverse reactions. Supporters of the vaccination program, however, say no credible evidence has been produced to show that it causes serious side effects.

The vaccine BioPort wants to produce involves six shots over 18 months. Critics have called this approach impractical and unreliable, urging BioPort researchers to concentrate on developing a new one.

"They've got a pretty profound problem," said Lawrence Halloran, staff director of the House Subcommittee on National Security, which investigated BioPort after it fell behind in its efforts to provide the vaccine to the military. "They can't demonstrate within any range of certainty that their vaccine is scientifically valuable."

Even if the company passes its next Food and Drug Administration inspection and is allowed to resume production, the first several million doses will be assigned for military use.

In recent days more than 1,200 people, including many doctors, have called BioPort asking to buy anthrax vaccine. They are transferred to a recording that says, "All the stockpile that currently exists is owned by the Department of Defense. At this time there is no opportunity for any commercial sales." The government has said it has no plans to vaccinate civilians.

The Defense Department is BioPort's only customer, and it has invested $126 million in the Lansing plant over the last decade. Military commanders say they want to immunize all 2.4 million active and reserve troops against anthrax but have so far managed to begin immunizing only about 500,000, mostly those in the Persian Gulf. There is no figure on the number who have received the full course of vaccination.

Michigan began producing anthrax vaccine in 1970, selling it to small numbers of animal handlers, mill workers and others who might be exposed to the disease. After the gulf war, demand grew.

In 1998, the state sold the plant to BioPort, a newly formed company whose most prominent board member is Adm. William J. Crowe Jr., a former chairman of the Joint Chiefs of Staff and former ambassador to Britain.

Some Lansing residents opposed the plant's privatization in 1998 and have been sharply critical of it since.

"They have never met their responsibilities," said Lingg Brewer, a former state legislator from Lansing."They bought the company at a fire-sale price with the help of political connections, and since then they have not been able to make any vaccine that meets F.D.A. standards. They're doing a lot of chest-thumping about protecting the nation's interest, but they're actually unwitting allies of our enemies because of their incompetence and their greed."

Robert Kramer, president of BioPort, who has been at odds with Mr. Brewer for years, rejected his charges.

"Mr. Brewer has made the same claims over and over again, and they have all been discounted by courts, by Congress and by appropriate state and federal agencies," Mr. Kramer said. "I find it unconscionable that at a time when our country is uniting around our military and the national assets that serve it, he will continue to make his irresponsible and unsubstantiated allegations. He is doing a disservice to the 220 employees of BioPort and, more importantly, to his country."

Concerns about BioPort are especially acute as officials in Washington begin reassessing the country's readiness to fend off biological attacks. One group of senators has introduced a bill calling for $1.4 billion to improve defenses against this form of terrorism.

The National Guard soldiers took up positions at BioPort on Monday and quickly installed a series of low concrete barriers near the front gate and began unrolling barbed-wire fencing. But until then the plant was separated from public streets by no more than a chain-link fence that a child could climb over.

"It's a joke," said a woman working at a state office building across the street. "We're nervous. Anything could happen."